Epileptiform discharges and the behavior of children with epilepsy

cifically we do not believe the title is misleading. The term toxic is warranted because these children either unintentionally ingested someone else’s clonidine or ingested greater than their prescribed dose. This is also supported by the fact that 72% of children experienced clonidine-related symptoms, such as drowsiness or lethargy. The fact that most children became symptomatic also addresses the second comment regarding whether these are confirmed ingestions. We disagree with the definition of the term “exposure.” Poison control centers do not use this term to denote cases in which it is unclear whether an ingestion occurred. Rather, the term is used by poison control centers because it is a route-neutral term and encompasses cases that involve routes other than ingestion. Finally, we are intrigued that they suggest that the only prospective cases worth reporting are those involving witnessed ingestions or with laboratory confirmation. One would hope parents would not watch children ingest See letter by Langhan large quantities of tablets and Chan (J Pediatr without stopping them. 2006;149:565). Confirmation of serum clonidine concentrations is not routinely available and not likely to be useful for triage decisions, which was one of the primary questions investigated in our study.2 We disagree that our conclusions are far-reaching. The recommendations for medical referral are relatively conservative. Not only are they based on the findings of this study, but also they are in line with therapeutic dosing and maximum daily doses for all 3 age groups. We agree that children who ingest an unknown dose should be referred for direct medical observation. Finally, we are also in the practice of protecting children from potential lethal complications and believe our recommendations are consistent with this practice. Henry A. Spiller, MS, D.ABAT Kentucky Regional Poison Center Louisville, KY Wendy Klein-Schwartz, Pharm.D Maryland Poison Center University of Maryland, School of Pharmacy Baltimore, MD 10.1016/j.jpeds.2005.12.002

REFERENCES 1. Langhan M, Chan G. Clonidine exposures, not toxicity. J Pediatr 2006;148:565. 2. Spiller HA, Klein-Schwartz W, Colvin JM, Villalobos D, Johnson PB, Anderson DL. Toxic clonidine ingestion in children. J Pediatr 2005;146:263-6.

form discharges improves behavior in children with epilepsy.1 This clinical trial addresses an important topic but has key deficiencies with regard to reporting of clinical trials. The electroencephalograms (EEGs) used for this research study are not standard of care for epilepsy (or behavior). The 12- to 24-hour EEG duration should have been disclosed in the abstract. The authors fail to report effect sizes on behavior outcomes. Results of randomized controlled trials should be reported in a transparent fashion that includes estimates of effect sizes and their precision.2 The authors provide an informative table with baseline characteristics. A similar table and crossover-study figure, stratified by EEG changes, showing effect sizes and confidence intervals for each treatment would be informative. Instead, the authors present their primary and secondary outcomes with F test results solely. Their acknowledgement in the Discussion that, in similar behavioral research, significant results may or may not be clinically relevant does not mitigate their responsibility to report the sizes of the effects they attribute to treating EEG discharges with lamotrigine. There also is no report of behavior changes among subjects with reduction in frequency or duration of 12- to 24-hour EEG discharges during placebo treatment. The authors present the statistical analysis incompletely. Both primary outcomes are reported as results of F tests, with marginal P values. F tests inform about statistical significance based on numerator and denominator degrees of freedom. However, the authors disclosed only single measures of degrees of freedom throughout the Results. Readers cannot readily or accurately interpret what model was being tested for each analysis. More descriptive and understandable reporting would be helpful to assess the authors’ conclusion that treating epileptiform discharges with lamotrigine improves behavior. Donald L. Gilbert MD, MS Associate Professor Pediatrics and Neurology Cincinnati Children’s Hospital Medical Center and University of Cincinnati Cincinnati, OH C. Ralph Buncher, ScD Professor of Biostatistics and Epidemiology University of Cincinnati Cincinnati, OH 10.1016/j.jpeds.2005.04.061

REFERENCES Epileptiform discharges and the behavior of children with epilepsy To the Editor: Pressler et al in a randomized controlled crossover trial addressed the question of whether reducing epileptiLetters

1. Pressler RM, Robinson RO, Wilson GA, Binnie CD. Treatment of interictal epileptiform discharges can improve behavior in children with behavioral problems and epilepsy. J Pediatr 2005;146:112-7. 2. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.[see comment]. Lancet 2001;357:1191-4.

283